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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251140

510(k) cleared

Zenflow Spring Scope

Zenflow, Inc. · Sep 23, 2025 · K251140 · In the directory

FDA cleared the Zenflow Spring Scope from Zenflow, Inc. on Sep 23, 2025 under K251140, a traditional 510(k). The device falls under product code FAJ, Cystoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 14, 2025. The decision came 162 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zenflow, Inc. has one other decision in the tracker over the last 12 months: P250007 (Zenflow Spring® Implant and Delivery System).

Questions & Answers

What did FDA clear under K251140?

K251140 is the FDA 510(k) for Zenflow Spring Scope, submitted by Zenflow, Inc.. FDA's decision date was Sep 23, 2025, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the Zenflow Spring Scope?

Zenflow, Inc., based in South San Francisco, CA, is the applicant of record for K251140. The company is listed in the MedDevice Startups directory.

How long did the K251140 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Sep 23, 2025, 162 days later.

← All decisions in September 2025

Sources

In the startup directory

Zenflow

GI & Urology · San Francisco, CA